OncoMatch/Clinical Trials/NCT05950464
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Is NCT05950464 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BET Bromodomain Inhibitor ZEN-3694 and Tuvusertib for recurrent endometrial carcinoma.
Treatment: BET Bromodomain Inhibitor ZEN-3694 · Tuvusertib — This phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Ovarian Cancer
Biomarker criteria
Allowed: ARID1A pathogenic alteration
Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II).
Allowed: ARID1A likely pathogenic alteration
Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II).
Allowed: ARID1A wild-type
Tumor will be determined as ARID1A pathologic alteration or likely pathologic alteration (Cohort I) or ARID1A wildtype by NGS (Cohort II).
Allowed: MSH2 deficient
Subjects with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
Allowed: MSH6 deficient
Subjects with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
Allowed: MLH1 deficient
Subjects with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
Allowed: PMS2 deficient
Subjects with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor — endometrioid endometrial cancer with MSI-H or dMMR
Subjects with microsatellite instability-high (MSI-H) and/or mismatch repair protein deficient (dMMR) endometrioid endometrial cancer must have previously received an immune checkpoint inhibitor.
Cannot have received: ATR inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Cannot have received: ATM inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Cannot have received: CHK inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Cannot have received: BET inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Cannot have received: EZH2 inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Cannot have received: PI3K inhibitor
Patients who have received prior ATR, ATM, CHK, BET, EZH2, and/or PI3K inhibitors.
Lab requirements
Blood counts
Hemoglobin >= 9 g/dL (in the absence of transfusion within 28 days prior to dosing); Absolute neutrophil count >= 1,500 cells/mm^3; Platelet count >= 100,000 cells/mm^3
Kidney function
Calculated creatinine clearance (CrCL) of >= 50 mL/min by the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x institutional ULN (patients with known Gilbert's disease who have bilirubin level <= 3 x ULN may be enrolled); AST and ALT <= 3 x institutional ULN
Cardiac function
Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents should be NYHA Functional Classification of class I or II; QTc must not be over 450 msec that does not correct with correction of electrolyte abnormalities or family history of long QT syndrome.
Hemoglobin >= 9 g/dL (in the absence of transfusion within 28 days prior to dosing) Absolute neutrophil count >= 1,500 cells/mm^3 Platelet count >= 100,000 cells/mm^3 Calculated creatinine clearance (CrCL) of >= 50 mL/min by the Cockcroft-Gault formula Total bilirubin <= 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level <= 3 x ULN may be enrolled) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 x institutional ULN Patients with known history or current symptoms of cardiac disease or history of treatment with cardiotoxic agents should be New York Heart Association (NYHA) Functional Classification of class I or II. Patients with corrected QT (QTc) over 450msec that does not correct with correction of electrolyte abnormalities or family history of long QT syndrome are excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Augusta University Medical Center · Augusta, Georgia
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
- University of Iowa/Holden Comprehensive Cancer Center · Iowa City, Iowa
- Wayne State University/Karmanos Cancer Institute · Detroit, Michigan
- University of New Mexico Cancer Center · Albuquerque, New Mexico
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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